ClinicalTrials.gg
Enrolling by invitationNCT07903012Updated Oct 29, 2026

A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars

A Phase 2/3 interventional study of polydioxanone (PDO) mono threads and Mono Threads with Plasma Gel in Acne, sponsored by Tanta University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Tanta University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Nov 2025, registered Oct 2026).
Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to evaluate and compare the efficacy and safety of mono threads alone versus mono threads combined with plasma gel for the treatment of atrophic post-acne scars. Using a prospective, randomized, split-face design, participants receive mono threads on both sides of the face, followed one month later by plasma gel injection on one side and saline injection on the other. Treatment outcomes are assessed using standardized clinical photographs, the Goodman Quantitative Global Scarring Grading System, the ECCA scar grading scale, qualitative scar severity grading, and patient-reported quality of life and satisfaction measures. The study also evaluates treatment-related adverse effects, including erythema, edema, pain, and ecchymosis. The findings aim to determine whether adding plasma gel to mono threads provides greater clinical improvement and better patient-reported outcomes than mono threads with saline.

02

Conditions studied

  • Acne

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Keywords

  • PRP
03

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 672 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years or older of either sex.
  • Patients with bilateral atrophic post-acne scars on the face.

Exclusion criteria

Exclusion Criteria

  • Active acne.
  • History of keloid scarring.
  • diseases.
  • Bleeding disorders.
  • Pregnancy or lactation.
  • Any treatment for acne scars within the preceding 6 months.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Mono Threads

    Participants receive polydioxanone (PDO) mono threads inserted into the mid dermis on the assigned side of the face using a cross-hatch technique. Six to ten threads are inserted according to acne scar severity. One month after thread insertion, plasma gel is injected into the mid and deep dermis and gently massaged into the skin. Clinical outcomes are assessed using standardized photographs, acne scar grading scales, and other study outcome measures.

    Drug: polydioxanone (PDO) mono threads

  • Active comparator
    Mono Threads with Plasma Gel

    Participants receive polydioxanone (PDO) mono threads on the assigned side of the face, followed by plasma gel injection one month later. Six to ten threads are inserted into the mid dermis using a cross-hatch technique, according to acne scar severity. Plasma gel is subsequently injected into the mid and deep dermis and gently massaged into the skin.

    Drug: Mono Threads with Plasma Gel

Interventions

  • Drugpolydioxanone (PDO) mono threads

    Participants receive polydioxanone (PDO) mono threads on the assigned side of the face, followed by saline injection one month later. Six to ten threads are inserted into the mid dermis using a cross-hatch technique, according to acne scar severity.

  • DrugMono Threads with Plasma Gel

    Drug page: Human plasma

    Participants receive polydioxanone (PDO) mono threads on the assigned side of the face, followed by plasma gel injection one month later. Six to ten threads are inserted into the mid dermis using a cross-hatch technique, according to acne scar severity. Plasma gel is subsequently injected into the mid and deep dermis and gently massaged into the skin.

    Also known as: Plasma

06

What researchers measure

Primary outcomes

  1. Number of participants with improvement

    Treatment outcome is assessed using standardized clinical photographs

    Time frame: 6 months

  2. Goodman Quantitative Global Scarring Score

    Change in Goodman Quantitative Global Scarring Score from baseline.

    Time frame: Baseline to 3 months after the final treatment session.

  3. ECCA Scar Score

    Change in the Echelle d'Évaluation Clinique des Cicatrices d'Acné (ECCA) score from baseline.

    Time frame: Baseline to 3 months after the final treatment session.

  4. Qualitative Scarring Grade

    Distribution of participants across mild, moderate, and severe acne scar grades.

    Time frame: Baseline and 3 months after the final treatment session.

07

Study locations

1 site
08

References and documents

Publications

  • Elfar NN, Hasby EA. Efficacy and safety of plasma gel as a new modality in treatment of atrophic acne scars. Int J Dermatol. 2020 May;59(5):620-626. doi: 10.1111/ijd.14815. Epub 2020 Feb 28. PubMed 32108322 ↗
  • Munjal A, Ferguson N. Diversity, Equity, and Inclusion Initiatives in Dermatology Organizations. Dermatol Clin. 2023 Apr;41(2):359-369. doi: 10.1016/j.det.2022.10.008. Epub 2023 Feb 1. PubMed 36933926 ↗

Related links

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication, including relevant clinical characteristics, acne scar severity scores, clinical improvement assessments, quality-of-life assessments, patient satisfaction, and safety outcomes, will be available upon reasonable request, subject to applicable ethical and privacy requirements.

Supporting information: Study protocol

Time frame: following publication

Access criteria: Requests should be submitted to the corresponding author with a brief description of the research objectives and intended use of the data. Access will be considered on a reasonable request basis, subject to ethical approval where applicable, protection of participant confidentiality, and any necessary data-sharing agreement.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 29, 2026
StartActual
Nov 10, 2025
Primary completionEst.
Nov 1, 2026
CompletionEst.
Nov 1, 2026
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07903012
Lead sponsor
Tanta University
Responsible party
Sameh Sarsik (Lecturer, Tanta University) — Principal investigator
First posted
Oct 29, 2026
Start date
Nov 10, 2025
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Oct 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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